Make your mark for patients
We are looking for a ( Bio)Process Engineer who is solutions minded to join us in our BioProcess Engineering team, based in Braine-l’Alleud , Belgium
About the role
The (Bio)Process Engineer will support the establishment and operation of clinical manufacturing equipment for UCB’s new Biologics and Gene Therapy product pipelines.
The role involves definition of equipment and single-use assemblies user requirements as well as supporting design and qualification for all relevant clinical manufacturing steps with specific focus on drug product processing equipment and single-use assemblies (formulation, sterile filtration and fill & finish). This will be performed in close collaboration with the operations, engineering-, qualification - and quality assurance departments.
Furthermore, you will act as the cleaning expert for upstream-downstream- and drug product manufacturing systems and as such plan and coordinate equipment cleaning optimization activities and validation in close collaboration with the validation department and manufacturing operations teams.
The (Bio)Process Engineer supports the manufacturing teams in troubleshooting challenges faced during the execution of manufacturing campaigns, in compliance with GMP rules and will act as one of the experts in manufacturing of biologics/rAAV at industrial scale within the entire UCB biotech organization.
What you’ll do :
Act as a Process Equipment Expert and BioProcess specialist for topics related to Drug Product (DP) production and cleaning/change-over strategy.
Provide DP manufacturing expertise to internal collaborators such as, clinical manufacturing, global engineering, qualification, and quality assurance.
Support design and qualification of DP process equipment. Generation of risk assessments and user specifications for manufacturing systems and single-use materials.
Development and refinement of a contamination control strategy for DP manufacturing.
Manage design and validation of cleaning and/or VHP treatment procedures.
Support generation of automation recipes on DP manufacturing equipment as user SME.
Ensure operational excellence and cGMP compliance.
Generate relevant documentation such as SOPs and risk assessments and review of validation protocols and reports.
Floor support and training of clinical manufacturing staff.
Support root-cause investigations, change controls, CAPA plan implementations in close collaboration with the QA department.
I nterested? For this role we’re looking for the following education, experience and skills
Master’s degree in a related field.
At least 5 years of industrial experience in pharmaceutical and/or biotech manufacturing systems and their automation. Specifically for (but not limited to) the fill and finish (F&F) equipment.
Expertise in cleaning of pharmaceutical equipment, cleaning validation and product changeover procedures (e.g. VHP treatment).
Expertise in sterility concepts, bioburden reduction approaches, including systematic troubleshooting.
Experience with process equipment qualification/validation.
Experience with highly automated cGMP processes, specifically with DCS such as PCS7 or DeltaV.
Knowledge of regulatory guidelines, CMC requirements and QbD principles.
Project Management skills.
Very good command in both English and French.
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!
